CureVac launches Phase IIa mRNA Vaccine Trial in Prostate Cancer
(Thomson Reuters ONE) - * First evaluation of CureVac's RNActive® vaccine technology in humans * German authorities approve CV9103 for Phase IIa trialTuebingen (Germany), November 2, 2009. CureVac GmbH, the mRNA vaccinecompany, today announced that the German authorities approved thestart of the Phase IIa trial in Prostate Cancer after assessment ofthe first safety data of lead candidate CV9103, a RNActive®-derivedmRNA vaccine. Results so far from the Phase I show CV9103 to be safeand well tolerated.The drug candidate CV9103, a first in class molecule, will be furtherdeveloped for the treatment of patients with hormone-refractorymetastatic prostate cancer. The Paul-Ehrlich Institut has approvedthe start of the Phase IIa with CV9103 to further evaluate thesafety, tolerability and biological activity of the vaccine. CureVachas now launched the Phase IIa in 21 patients with CV9103 viaintradermal injection (multiple-dose). First results from this trialare expected by H2 2010.CV9103 is the most advanced candidate in CureVac's vaccine pipelineof RNActive®-derived molecules for the active immunotherapy ofcancer. The vaccine is comprised of modified mRNA molecules codingfor four different antigens expressed by prostate cancer cells."This is the first evaluation of CureVac's RNActive® platform inhumans," said Ingmar Hoerr, Managing Director of CureVac. "We areconfident that mRNA vaccines have the potential to become a novelclass of broadly applicable therapeutic agents addressing large areasof immunotherapy. In combination with the attractive preclinicalprofile the results we have seen in the Phase I study stronglysupport our plans to develop CV9130 as a safe and efficacioustreatment of prostate cancer." ###About CureVacCureVac GmbH is a biopharmaceutical company specializing in theprophylactic and therapeutic application of messenger RNA (mRNA).CureVac's lead programme is dedicated to the development of tumourvaccines and active immunotherapies (based on its RNActive®-derivedmolecules) for the treatment of prostate cancer and non-small celllung cancer.Currently, there are two candidates in clinical stage: CV9103 totreat prostate cancer, which is in the U.S. and Europe the mostcommon cancer and the second leading cause of cancer death in men.Additionally, CV9201, to treat non-small cell lung cancer (NSCLC), isbeing tested in Germany and Switzerland. Lung cancer affects morethan 1.4 million people worldwide and is the leading cause of cancerdeath.CureVac, a spin-off from the Tuebingen University, Germany, wasestablished in December 2000 and is headquartered in Tuebingen withclinical development facilities in Frankfurt. Since its inception,the Company has raised approximately EUR 38 million. The principalinvestor of the company is dievini Hopp BioTech holding GmbH&Co. KG,a venture capital firm owned by the Hopp family.RNActive®, RNAdjuvant®, PUREmessenger® are registered trademarks ofCureVac GmbH.About CureVac's mRNA-derived Technology PlatformsMessenger ribonucleic acid (mRNA) is a genetic template for proteinsynthesis. It delivers the information encoded by genes from DNA toribosomes where the information is translated into individualproteins. Natural RNA is an unstable biomolecule that is rapidlydigested in the human body. As a result, its potential role as atherapeutic has been overlooked for decades.CureVac has proved it is possible to modify mRNA making it suitablefor therapeutic purposes and maintaining its physiologicalproperties. CureVac's RNActive®-derived customized mRNA molecules areused to encode different tumour-associated antigens which areexpressed by cells residing in the upper layers of the skin. Hence,the immune system will recognize these antigens on presentation todendritic cells and react by forming both antigen-specific T-cellsand humoral antibodies.Building on its unique expertise from many years of RNA research,molecular design and RNA production the Company has establishedseveral proprietary technologies, namely: * RNActive® for the design and formulation of modified mRNA serving a broad range of applications like therapeutic and prophylactic vaccines * RNAdjuvant® as an immune stimulant to improve the efficacy of prophylactic and therapeutic vaccines, * PUREmessenger® for the cGMP-production of full-length mRNA within a short timeframe.The combination of these technologies enables the Company to designand manufacture mRNA for a broad range of applications.ContactCureVac GmbHMarijke Barner, PhDPaul-Ehrlich-Str. 1572076 TübingenGermanyT +49 (0) 70 71.92 0 53-0F +49 (0) 70 71.92 0 53-11Marijke.Barner(at)curevac.comwww.curevac.comMC Services AGHilda JuhaszT +49 (0) 89.210 228 20Hilda.Juhasz(at)mc-services.euhttp://hugin.info/141325/R/1351700/326791.pdfThis announcement was originally distributed by Hugin. The issuer is solely responsible for the content of this announcement.
Datum: 02.11.2009 - 08:30 Uhr
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